FDA Registration
Active
🇨🇳 China
ONE STEP DRUGS OF ABUSE
Reg #: 3004635103
·
FEI: 3004635103
·
Expires 2025
Products
11
Proprietary Names
13
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Registration Number
- 3004635103
- FEI Number
- 3004635103
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.8 Lizhishan Road, Science City, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K050024
Owner / Operator
- Firm Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Operator Number
- 9064561
- Address
- No.8 lizhishan Road, Science City, Huangpu District, 510663
- City
- GUANGZHOU
- State
- Guangdong
- Postal Code
- 510663
- Country
- CN
- Correspondent
- Jihua - Wang
US Agent
- Business Name
- LSI International Inc.
- Contact Name
- Joe Shia
- Address
- 504 East Diamond Ave., Suite I
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 5057880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2006-12-01 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2006-12-01 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2006-12-01 |
Proprietary Names
ONE STEP DRUGS OF ABUSE
One Step Benzodiazepines Urine Test
One Step Amphetamine Urine Test
One Step Methamphetamine Urine Test
One Step Barbiturates Urine Test
One Step Tricyclic Antidepressants Urine Test
One Step Methylenedioxymethamphetamine Urine Test
One Step Morphine Urine Test
One Step Phencyclidine Urine Test
One Step Methadone Urine Test
One Step Marijuana Urine Test
One Step Opiate Urine Test
One Step Cocaine Urine Test
Establishment Types
Manufacture Medical Device